Zhou Qin, Qin Wen-Zhe, Liu Shuai-Bin, Kwong Joey S W, Zhou Jing, Chen Jin
Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2014 Apr 14(4):CD005052. doi: 10.1002/14651858.CD005052.pub5.
Heart failure is a major public health problem worldwide. Shengmai, a traditional Chinese herbal medicine, has long been used as a complementary treatment for heart failure in China. This is an update of a Cochrane Review published in 2012.
To determine the effect (both benefits and harms) of Shengmai in treatment of people with heart failure.
We searched CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE (1948 to June Week 1 2013); EMBASE (1980 to 2013 Week 23); AMED (1985 to August 2008); BIOSIS (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1989 to June 2013); and CNKI (1979 to June 2013). We also handsearched Chinese journals and did not apply any language restrictions.
We included randomised controlled trials (RCTs) of Shengmai plus usual treatment for heart failure versus usual treatment alone, or Shengmai versus placebo, irrespective of blinding status. In this update we only included studies with a clear description of randomisation methods and classified as true RCTs.
Two authors independently selected trials, assessed methodological quality and extracted data. We calculated dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) or standardized mean differences (SMDs) with corresponding 95% confidence intervals (CIs). We used a fixed-effect model to perform meta-analysis for outcomes without heterogeneity; and a random-effects model to perform meta-analysis for outcomes with heterogeneity.
We included a total of 14 RCTs (858 patients) in this review update, four of which were new trials. Of these 14 RCTs, 11 trials compared Shengmai plus usual treatment with usual treatment alone, and three trials compared Shengmai with placebo. Improvement of NYHA functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (RR 0.37; 95% CI 0.26 to 0.51; 10 trials, 672 participants; low quality evidence). Beneficial effects of Shengmai in treating heart failure were also observed in other outcomes, including exercise test, ejection fraction and cardiac output. The three RCTs (106 patients) comparing Shengmai with placebo reported improvement in NYHA functional classification and in stroke volume. Three of the 14 RCTs reported a total of six patients with mild adverse effects and two were withdrawn due to the adverse effects. The adverse events rate was 1.21%.
AUTHORS' CONCLUSIONS: Shengmai may exert a positive effect on heart failure, especially for improving NYHA functional classification when Shengmai plus usual treatment is used. The review results should be interpreted with caution due to the high risk of bias of the included studies (particularly regarding allocation concealment and blinding), the small sample size of these studies, and the significant heterogeneity in outcomes such as ejection function, cardiac output and stroke volume. There was no evidence available concerning the effect of Shengmai on mortality, and more high quality studies with long-term follow-up are warranted.
心力衰竭是全球主要的公共卫生问题。生脉，一种传统中药，在中国长期被用作心力衰竭的辅助治疗。这是对2012年发表的一篇Cochrane系统评价的更新。
确定生脉治疗心力衰竭患者的效果（益处和危害）。
我们检索了Cochrane图书馆中的CENTRAL（2013年4月第12期第5卷）；Cochrane图书馆中的DARE（2013年4月第4期第2卷）；MEDLINE（1948年至2013年6月第1周）；EMBASE（1980年至2013年第23周）；AMED（1985年至2008年8月）；BIOSIS（1969年至2013年6月7日）；CBM（1978年至2013年6月）；VIP（1989年至2013年6月）；以及CNKI（1979年至2013年6月）。我们还手工检索了中文期刊，且未设任何语言限制。
我们纳入了生脉联合常规心力衰竭治疗与单纯常规治疗对比，或生脉与安慰剂对比的随机对照试验（RCT），无论其是否采用盲法。在本次更新中，我们仅纳入了对随机化方法有清晰描述且归类为真正RCT的研究。
两位作者独立选择试验、评估方法学质量并提取数据。我们将二分数据计算为风险比（RRs），将连续数据计算为均值差（MDs）或标准化均值差（SMDs）以及相应的95%置信区间（CIs）。对于无异质性的结局，我们采用固定效应模型进行Meta分析；对于有异质性的结局，我们采用随机效应模型进行Meta分析。
在本次系统评价更新中，我们共纳入了14项RCT（858例患者），其中4项为新试验。在这14项RCT中，11项试验比较了生脉联合常规治疗与单纯常规治疗，3项试验比较了生脉与安慰剂。与单纯接受常规治疗的患者相比，接受生脉联合常规治疗的患者中纽约心脏协会（NYHA）功能分级改善更为常见（RR 0.37；95%CI 0.26至0.51；10项试验，672名参与者；低质量证据）。在其他结局中也观察到生脉治疗心力衰竭的有益效果，包括运动试验、射血分数和心输出量。比较生脉与安慰剂的3项RCT（106例患者）报告了NYHA功能分级和每搏输出量的改善。14项RCT中的3项共报告了6例有轻度不良反应的患者，2例因不良反应退出研究。不良事件发生率为1.21%。
生脉可能对心力衰竭发挥积极作用，尤其是在采用生脉联合常规治疗时对改善NYHA功能分级有作用。由于纳入研究存在较高的偏倚风险（特别是在分配隐藏和盲法方面）、研究样本量小以及射血功能、心输出量和每搏输出量等结局存在显著异质性，对本系统评价结果的解读应谨慎。尚无关于生脉对死亡率影响的证据，因此需要更多高质量的长期随访研究。
